Is my BBraun IV admin set recalled?

Check the catalog numbers 490469 and 490470 on the package or accompanying labeling. The recall covers these two items worldwide.

What should I do if I own one of these IV sets?

Stop using the product immediately. Contact BBraun Medical Inc for recall instructions and refund or replacement options.

What is the primary hazard?

Backflow from secondary piggyback IV containers into the primary container and an inability to prime the line.

Are there any reported injuries?

No injuries or incidents are listed in the recall notice. The safety risk is elevated due to the potential malfunction.

How long will refunds take?

Refund or replacement timelines are issued by the manufacturer and may vary; expect several weeks after verification.

Where can I find more information?

Refer to FDA enforcement reports Z-0607-2026 and BBraun Medical’s recall notification.

What documentation should I keep?

Save labeling, catalog numbers, UDI-DI codes, and all correspondence with BBraun Medical.

What other products are affected?

Only the two catalog numbers listed in the recall are affected.

Who regulates this recall?

The recall is listed with U.S. FDA enforcement and BBraun Medical’s recall notice.

HIGHOctober 29, 2025

BBraun Medical Inc. Recalled 104,784 Anesthesia IV Sets Over Backflow, Occlusion Risk

Q: Can the device be used with all BBraun pumps?

The recall applies to sets used with Infusomat Space, Outlook, and Vista Basic pumps as specified.

BBraun Medical Inc. recalled 104,784 Anesthesia IV Sets used with Infusomat Space, Outlook, and Vista Basic pumps. The recall cites backflow of medication from secondary to primary IV containers and a potential inability to prime. Health care providers should stop using the devices immediately and follow the manufacturer’s recall instructions for refund or replacement.

Quick Facts at a Glance

Recall Date: October 29, 2025
Hazard Level: HIGH
Brand: BBraun Medical
Category: Health & Personal Care
Sold At: Unknown
At-Risk Groups: GENERAL, PREGNANT, ELDERLY

Hazard Information

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter

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About This Product

IV admin sets deliver medications or fluids during medical procedures. This recall concerns piggyback setups in gravity or pump-assisted lines.

Why This Is Dangerous

Backflow can lead to misdose or contamination and line occlusion can interrupt infusion, potentially impacting patient safety.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

Immediate action required in clinical settings. Utilities and refunds may take weeks; patient safety depends on stopping use and replacing with approved sets.

Practical Guidance

How to identify if yours is affected

Inspect catalog numbers on packaging: 490469 and 490470.
Cross-check UDIs: 04046964958816, 04046964958809, 04046964958830, 04046964958823.
Confirm compatibility with Infusomat Space, Outlook, and Vista Basic pumps.

Where to find product info

UDI labels on packaging and device labeling; recall notice on FDA enforcement page.

What timeline to expect

Refunds or replacements are issued per manufacturer directions; typical processing spans several weeks.

If the manufacturer is unresponsive

File a complaint with the FDA if the company is slow to respond.
Document all attempts to contact the manufacturer.

How to prevent similar issues

Verify catalog numbers and UDIs before use.
Use only approved IV sets that match your pump model.
Stay updated with FDA recall notices for new guidance.

Documentation advice

Keep packaging labels, UDIs, recall notices, and correspondence with BBraun Medical.

Product Details

Catalog Numbers: 490469 and 490470. Description: IV Admin Set with 15 drops/mL, 132 in; 60D 2 CARESITE VLV, 132 in. Primary UDI-DI: 04046964958816; Unit of Dose UDI-DI: 04046964958809. Secondary Catalog Number: 490470; Primary UDI-DI: 04046964958830; Unit of Dose UDI-DI: 04046964958823. Sold worldwide including US, Canada, Germany, Guatemala, Singapore.

Reported Incidents

No specific incident counts are provided in the recall notice. The FDA enforcement page lists the hazard and quantity but does not enumerate injuries or incidents.

Key Facts

104,784 units recalled worldwide
Catalog Numbers 490469 and 490470
Primary UDI-DI 04046964958816; 04046964958830
Unit of Dose UDI-DI 04046964958809; 04046964958823
Recall status: ACTIVE as of 2025-12-03

View Original Recall on FDA - Medical Devices

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERALPREGNANTELDERLYINFANTSCHILDREN

Injury Types

ELECTRICALLACERATIONOTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeIV Administration Set

Product Details

Oct 29, 2025

BBraun Medical

Potential for